A Clinical Study Evaluating Temporary Transvenous Diaphragm Neurostimulation in Mechanically Ventilated Patients With Acute Hypoxemic Respiratory Failure

Lungpacer Medical Inc.

Summary

Multi-center, randomized, controlled, open-label Phase 2 feasibility trial. Subjects on mechanical ventilation (MV) for acute hypoxemic respiratory failure (AHRF) with lung injury (including subjects who meet criteria for acute respiratory distress syndrome (ARDS)) will be randomized 2:1 to diaphragm neurostimulation-assisted ventilation (DNAV) using the AeroNova System plus lung-protective ventilation (Treatment) vs. lung-protective ventilation alone (Control).

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Male or female, 18 years or older, and 2. Able to provide informed consent or have a legally authorized representative (LAR) / Substitute Decision Maker (SDM) who can provide consent, and 3. Have acute onset of new respiratory symptoms or dysfunction within the 2 weeks before onset of need for respiratory support, and 4. Have arterial hypoxemia defined by one of: * PaO2:FiO2 ratio ≤300 mm Hg on PEEP ≥5 cm H2O, or * In the absence of an available arterial blood gas, SpO2 ≤97% on FiO2 ≥0.5 and PEEP ≥5 cm H2O with reliable SpO2 trace for the 2 hours immediately prec…

Interventions

Device
Phrenic Nerve Stimulation
During controlled MV when patients are not breathing, continuous diaphragm neurostimulation-assisted ventilation (DNAV) will be delivered in synchrony with each ventilator-delivered breath.

Locations (6)

University of California San Diego
La Jolla, California
Louisiana State University Health Sciences
Shreveport, Louisiana
Cleveland Clinic
Cleveland, Ohio
Temple University
Philadelphia, Pennsylvania
Prisma Health
Columbia, South Carolina
University Health Network (UHN)
Toronto, Ontario